- Approval Id
- 5159fd9ba3f0bf32
- Drug Name
- SALOFALK ENEMAS 4 G/60 ML
- Product Name
- SALOFALK ENEMAS 4 G/60 ML
- Approval Number
- SIN10918P
- Approval Date
- 1999-05-06
- Registrant
- DCH AURIGA SINGAPORE
- Licence Holder
- DCH AURIGA SINGAPORE
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- ENEMA
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p><u>Adults and elderly</u><br>
The following dosage guidelines are generally applicable:<br>
In patients with symptoms of acute inflammation, the content of 1 enema bottle (Salofalk 4 g/60 ml enemas) resp. 2 enema bottles (Salofalk 2 g/30 ml enemas) is administered into the intestine as an enema once daily at bedtime.</p>
<p><u>Children</u><br>
There is little experience and only limited documentation for an effect in children.</p>
<p><u>Method of administration</u></p>
<p>Rectal use.<br>
The best results are achieved if the bowel is emptied before administration of the Salofalk enema.</p>
<p>The desired therapeutic result can only be achieved if Salofalk enemas are used regularly and consistently.</p>
<p>The duration of treatment is determined by the patient’s doctor.</p>
<p>Acute attacks of ulcerative colitis usually regress after 8–12 weeks, after which Salofalk 2 g/30 ml / 4 g/60 ml enemas should not generally be used.</p>
<p><u>Preparation</u></p>
<ul class="dash">
<li>The bottle should be shaken for 30 seconds.</li>
<li>Then the protective cap of the applicator removed.</li>
<li>The bottle should be held at the top and bottom.</li>
</ul>
<p>The correct position for administration is as follows:</p>
<ul class="dash">
<li>The patient should lie down on his/her left side with his/her left leg stretched out and right leg bent. This makes it easier for the enema to be administered and for the enema to be effective.</li>
</ul>
<p><u>Administration of the rectal suspension</u></p>
<ul class="dash">
<li>The tip of the applicator should be inserted deep into the rectum.</li>
<li>The bottle should be tipped downwards slightly and then squeezed slowly.</li>
<li>Once the bottle is empty, the applicator tip should be slowly withdrawn from the rectum.</li>
<li>The patient should remain lying down in this position for at least 30 minutes to allow the contents of the enema to spread throughout the rectum.</li>
<li>If possible, the rectal suspension should be allowed to exert its effects all night.</li>
</ul>
- Route Of Administration
- RECTAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Acute attacks of ulcerative colitis (a chronic inflammatory disease of the large bowel)</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Salofalk enemas must not be used in patients with</p>
<ul class ="dash">
<li>known hypersensitivity to the active substance, to salicylates or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em></li>
<li>severe impairment of hepatic or renal function</li>
</ul>
- Atc Code
- A07EC02
- Atc Item Name
- mesalazine
- Pharma Manufacturer Name
- DCH AURIGA SINGAPORE
